EP2717957A1 - Canule artérielle pour chirurgie cardiaque - Google Patents

Canule artérielle pour chirurgie cardiaque

Info

Publication number
EP2717957A1
EP2717957A1 EP12732558.7A EP12732558A EP2717957A1 EP 2717957 A1 EP2717957 A1 EP 2717957A1 EP 12732558 A EP12732558 A EP 12732558A EP 2717957 A1 EP2717957 A1 EP 2717957A1
Authority
EP
European Patent Office
Prior art keywords
cannula
stopper
pledget
introducer
arterial
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP12732558.7A
Other languages
German (de)
English (en)
Other versions
EP2717957B1 (fr
Inventor
Mattia GLAUBER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
GLAUBER, MATTIA
Original Assignee
Glauber Mattia
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Glauber Mattia filed Critical Glauber Mattia
Publication of EP2717957A1 publication Critical patent/EP2717957A1/fr
Application granted granted Critical
Publication of EP2717957B1 publication Critical patent/EP2717957B1/fr
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
    • A61B2017/3425—Access ports, e.g. toroid shape introducers for instruments or hands for internal organs, e.g. heart ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
    • A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
    • A61B2017/3488—Fixation to inner organ or inner body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system
    • A61M2210/127—Aorta

Definitions

  • ARTERIAL CANNULA FOR CARDIAC SURGERY
  • the present invention refers to the field of surgery devices and in particular to an arterial cannula for cardiac surgery, particularly suitable for mini-invasive cardiac surgery.
  • Cardiac surgery includes the need to provide some sort of extracorporeal circulation where the blood is oxygenated as the cardiac surgeon makes surgical corrections to the patient's still heart.
  • the state of the art has evolved to a more "minimally invasive" approach which is based on trying to reduce the size of the surgical incision made in the patient's chest from a fully opened chest at the sternum (full sternotomy) to an approach that results in a smaller incision either via a partial cut of the sternum (mini-sternotomy) or an approach between the ribs (mini thoracotomy) depending on the pathology.
  • mini-sternotomy partial cut of the sternum
  • mini thoracotomy mini thoracotomy
  • the ability to see into the operating field is often quite limited, meaning that the instruments for this type of procedure are specialized.
  • the cannula used in these types of procedures are also specialized, with cannula being used as a physical conduit bringing blood to and from the patient as it goes through the extracorporeal circuit.
  • This extracorporeal circuit is used to pump, oxygenate, and temperature regulate the patient's blood during the operative course of the procedure.
  • the point at which blood comes back into the patient is referred to as an arterial cannula, meaning the arterial blood needed by the patient's body is pumped through the arterial cannula and into the actual patient's arterial vasculature.
  • the arterial cannulation site can be in a number of different locations including for example the ascending aorta, the aortic arch, the femoral aortic, or any other principal arteries.
  • Objective of the present invention is to provide an arterial cannula for cardiac surgery which could allow safe single wall arteria incision with minimal blood loss during insertion and removal and said cannula combined with a system that could help the guiding of the cannula and meanwhile facilitate the fixation and stabilization at the site of cannulation .
  • an arterial cannula (100) for cardiac surgery comprising:
  • the cannula disclosed above is intended to facilitate the cannulation and improve the safety of aortic cannulation as compared to conventional techniques for aortic cannulation.
  • FIG. 1 (A) shows the cannula (100) of the invention engaged with the stopper/pledget (101 /102) assembly which is fixed on the vessel (103); also the introducer (104) is shown in the figure;
  • FIG. 1 (B) shows the cannula/introducer (100/104) assembly, according to the invention, not yet engaged with the stopper/pledget (101 /102) assembly already fixed at the vessel (103) to be cannulated; the blade or sharp edge of the introducer, protruding from the tip of the cannula is visible in this figure;
  • FIG.2 shows a detail of the stopper/pledget (101 /102) assembly already fixed at the vessel (103) to be cannulated; in the embodiment shown in this figure the pledget is secured to the vessel by means of a minimum of two suture lines (106) and the stopper is engaged to the pledget by means of a suture with an exposed loop (107);
  • FIG. 3 shows the detail of the cannula (100), according to the invention, when it is in place into the vessel (103) and it is mechanically engaged to the pledget/stopper (101 /102) assembly by means of a mechanical joint (108) and it is further secured, for not protruding to far into the vessel, by means of a molded feature (109) which, stopping against the stopper, permits the cannula to enter the aorta only to a fixed dept;
  • FIG. 4 shows tourniquets (1 1 1 ) removably attached to the external body of the cannula (100); the suture lines (106), which secures the pledget/stopper (101 /102) assembly to the vessel can be introduced into said tourniquets in order to guide the cannula exactly to the cannulation site predisposed by the pledget/stopper (101 /102) assembly.
  • the cannula according to the invention includes three separate components, the cannula body (100), the pledget and stopper assembly (101 /102), and the introducer (104).
  • the cannula shape and its dimensions are preferably according to those already known in the art.
  • the introducer (104) is a semi rigid tube placed coaxially inside the cannula to facilitate cannula placement and can include a hole for wire introducer commonly used to guide the introducer and cannula assembly to the required location.
  • the introducer can be made from a semi-rigid material such as a polyolephin or other plastic that will assist in guiding the cannula assembly to the designated cannulation site.
  • the introducer includes a sharp end that protrudes past the cannula tip, either the material itself being sharp enough to piece the vessel at the cannulation site or a small blade 1 to 3 mm in depth could be included in the introducer tip to permit simple and easy vessel penetration at the cannulation site.
  • the tip of the cannula can be designed in any shape or manner desired to reduce the damage to the blood or improve the flow out of the cannula, in this embodiment the minimum recommended tip depth into the vessel is 10 mm.
  • the tip of the cannula has a diameter smaller than the introducer in order to avoid that the introducer blade or sharp edge could protrude outside the cannula tip more than 1 -5 mm, more preferably 1 -3 mm.
  • the pledget and stopper assembly (101/102) mates, snaps or otherwise interfaces with the external body of the cannula, engaged in a mechanical joint (108) based on interference or a ball-detent mechanism or male/female joint similar to that found on an ink pen cap.
  • the stopper prevents the cannula and introducer assembly from moving too deeply into the cannulation site beyond a point established by the design of the stopper, and acts as a safety mechanism preventing accidental puncture of the opposite wall of the blood vessel being cannulated.
  • the external cannula body could present a molded feature (109) that permits the cannula to enter the aorta to a fixed depth, no more (the maximum recommended tip depth into the vessel is 15 mm).
  • the molded feature (109) is a, further to the mechanical engagement (108), second secure stopper at the stopper.
  • the introducer and cannula assembly piece the vessel to a fixed depth established by the design of the stopper. Once the cannula is in place in the stopper, the introducer is withdrawn and thrown away. The introducer is withdrawn in a hemostatic manner, meaning that the cannula fills with blood as the introducer is withdrawn, and when the introducer is almost completely out of the cannula, the surgeon then clamps the proximal end of the cannula, preventing blood from coming out of the cannula.
  • the pledget-stopper assembly (101 and 102) are sutured to the vessel to be cannulated (103) and is used to guide the cannula and introducer (100 and 104), with the cannulation site being at the center of the pledget-stopper assembly .
  • the pledget can made in such a way that once the cannula and stopper are extracted, the pledget (102) remains connected to the vessel (103).
  • the pledget-stopper assembly may include a minimum of two suture lines (106) that are used to fix the pledget to the vessel to be cannulated; these suture lines can be included in the assembly or may be fixed onto the pledget by the surgeon manually.
  • the stopper can be made of any material, preferably a polycarbonate or other moldable plastic that interfaces mechanically with the tip of the cannula as described above.
  • the pledget is made from typical pledget/bandage material, like a sturdy wool or other bandage material that is flexible enough to take the shape of the curvature of the vessel (103) to which it is attached.
  • the sutures included on the pledget are used to sew the assembly to the vessel. A minimum of two sutures with needles included at each end of the suture line are preferable but more than two lines can easily be included as an improvement or other embodiment of the invention.
  • the pledget is then used to close the hole left behind in the vessel (i.e. cannulation site) preventing blood loss.
  • This is a very advantageous additional feature of the invention because the surgeon often does not have clear visible access to the aorta and cannulation site in a MICS mini thoracotomy or mini sternotomy approach. Being able to leave a pledget on the vessel and using the suture lines (106) to close the vessel, as described below, is therefore highly advantageous due to this lack of visualization.
  • the pledget and stopper are preferably each other joined mechanically in a manner that will permit easy detachment of the stopper once the procedure is complete and the cannula needs to be removed.
  • One embodiment could be using a suture with an exposed loop (107) joining the stopper to the pledget; the exposed loop could be cut, breaking the suture which joins the stopper to the pledget, so that the suture line could be extracted, freeing the stopper from the pledget.
  • the stopper remains attached to the cannula and is extracted along with the cannula when the assembly is removed, while the pledget remains attached to the vessel.
  • the vessel By crossing the sutures (106) the vessel can be easily closed when the sutures are crossed and tied off manually with a knot or using a more sophisticated tie off technique, permitting simple closure of the cannulation site. Again, at least two suture lines would be required, however any number more than two could be realized in this design.
  • a method for aligning the central axis of the stopper with the tip of the cannula is highly advantageous.
  • Such a technique can permit the proper landing of the cannula tip to the seat of the pledget stopper assembly, and can be provided quite easily by the use of the suture strings (106) and a mechanical guide on the body of the cannula which permits the use of the suture strings to guide the tip of the cannula directly into the stopper.
  • These same suture strings (106) can then be placed into a tube (typically called a tourniquet (1 1 1 ) and mechanically attached diametrically opposed to the external surface of the cannula. This allows the tourniquet assembly with the suture lines inside to be safely secured out of the field of view, which is important particularly if the surgical incision and consequent surgical field is quite small.

Abstract

La présente invention concerne une canule artérielle (100) pour chirurgie cardiaque, qui comprend : (a). un ensemble compresse/un bouchon (102)/(101) se couplant mécaniquement à la surface externe de la canule à proximité de sa pointe ; (b). un introducteur (104), qui a une dimension adaptée pour être placé coaxialement à l'intérieur de la canule, ledit introducteur ayant au niveau de son extrémité une lame ou un bord affûté qui dépasse de la pointe de la canule d'au plus 5 mm. La canule est adaptée à la chirurgie cardiaque, et notamment à une chirurgie cardiaque minimalement invasive.
EP12732558.7A 2011-06-07 2012-06-06 Canule artérielle pour chirurgie cardiaque Not-in-force EP2717957B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT000116A ITFI20110116A1 (it) 2011-06-07 2011-06-07 Arterial cannula for cardiac surgery.cannula arteriosa per chirurgia cardiaca.
PCT/EP2012/060715 WO2012168306A1 (fr) 2011-06-07 2012-06-06 Canule artérielle pour chirurgie cardiaque

Publications (2)

Publication Number Publication Date
EP2717957A1 true EP2717957A1 (fr) 2014-04-16
EP2717957B1 EP2717957B1 (fr) 2018-01-31

Family

ID=44554602

Family Applications (1)

Application Number Title Priority Date Filing Date
EP12732558.7A Not-in-force EP2717957B1 (fr) 2011-06-07 2012-06-06 Canule artérielle pour chirurgie cardiaque

Country Status (7)

Country Link
US (1) US20140200551A1 (fr)
EP (1) EP2717957B1 (fr)
JP (1) JP6034858B2 (fr)
AU (1) AU2012266415B2 (fr)
CA (1) CA2837421C (fr)
IT (1) ITFI20110116A1 (fr)
WO (1) WO2012168306A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017066495A1 (fr) * 2015-10-13 2017-04-20 Entourage Medical Technologies, Inc. Configurations de fermeture chirurgicale
EP3634528B1 (fr) 2017-06-07 2023-06-07 Shifamed Holdings, LLC Dispositifs de déplacement de fluide intravasculaire, systèmes et procédés d'utilisation
CN111556763B (zh) 2017-11-13 2023-09-01 施菲姆德控股有限责任公司 血管内流体运动装置、系统
EP4085965A1 (fr) 2018-02-01 2022-11-09 Shifamed Holdings, LLC Pompes à sang intravasculaires et procédés d'utilisation et de fabrication

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Publication number Priority date Publication date Assignee Title
US648863A (en) 1899-12-16 1900-05-01 George W Fair Camp-stool.
JP2694384B2 (ja) * 1990-11-26 1997-12-24 日本ゼオン株式会社 医療用チューブ及び医療用チューブ保持具
US5474539A (en) * 1991-02-07 1995-12-12 Origin Medsystems, Inc. Trocar with retracting tip
AU781509B2 (en) * 2000-01-26 2005-05-26 James R. Gannoe Vascular incisor and method
US20040102730A1 (en) * 2002-10-22 2004-05-27 Davis Thomas P. System and method for facilitating hemostasis of blood vessel punctures with absorbable sponge
JP4250169B2 (ja) * 2004-01-16 2009-04-08 株式会社トップ 留置針
US9283314B2 (en) * 2005-09-21 2016-03-15 Abiomed, Inc. Cannula systems
CA2628833C (fr) * 2005-11-07 2014-05-13 Flexicath Ltd. Adaptateur amovible pour systeme d'introduction divisible et procede d'utilisation correspondant
US7905884B2 (en) * 2006-04-27 2011-03-15 Warsaw Orthopedic, Inc. Method for use of dilating stylet and cannula
EP2046420B1 (fr) * 2006-08-02 2014-03-26 Unomedical A/S Dispositif d'insertion
EP2099384B1 (fr) * 2006-11-28 2018-09-05 Roche Diabetes Care GmbH Dispositif d'insertion et procédé pour insérer un élément insérable de manière sous-cutanée à l'intérieur d'un corps
WO2010071810A1 (fr) * 2008-12-19 2010-06-24 Andy Christopher Kiser Procédés et dispositifs pour un accès endoscopique au coeur

Non-Patent Citations (1)

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Title
See references of WO2012168306A1 *

Also Published As

Publication number Publication date
ITFI20110116A1 (it) 2012-12-08
US20140200551A1 (en) 2014-07-17
JP6034858B2 (ja) 2016-11-30
AU2012266415B2 (en) 2015-01-22
CA2837421C (fr) 2017-02-28
CA2837421A1 (fr) 2012-12-13
JP2014523760A (ja) 2014-09-18
EP2717957B1 (fr) 2018-01-31
WO2012168306A1 (fr) 2012-12-13

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